First patient safety trials of new cornea transplant technique to take place in India

Researchers in the Department of Materials Science and Engineering and the L.V. Prasad Eye Institute, Hyderabad have announced the approval by the Indian Regulatory Authority of the first in-man clinical trials of their jointly developed new technique, delivering stem cell therapy into the eye to address the loss of vision due to scarring of the cornea.

After more than 4 years of collaboration between the organisations in India and the UK, the Wellcome Trust-funded trials will begin in India in Autumn 2015 and involve 10 patients, all of whom have sustained injuries to one of their eyes, primarily through either industrial or cooking accidents, causing chemical burns.

They will be treated by using a very small piece of tissue from the patient’s unaffected eye. This is cut into about 8/10 small pieces (which contain the corneal stem cells) and lightly attached to a synthetic biodegradable membrane which is then placed onto the damaged eye. This membrane, made of the same material as dissolvable sutures, provides a secure surface for new, healthy corneal cells to grow out from the stem cells present in the tissue pieces. After a few weeks, this membrane dissolves, leaving the new cells securely attached to the eye. The new corneal surface is formed to replace the original scarred surface, and based on previous work using a different material to deliver the cells, is likely to improve their vision to a useful extent.

The membranes used in these first trials will be produced by the Electrospinning Company in the UK, under rigorous health and safety and manufacturing conditions suitable for this first in-man study.

This new technique offers an affordable way of treating damage to the cornea, the transparent layer on the front of the eye, which is one of the major causes of blindness in the world. Corneal blindness affects around 8-10 million people in India and of these, around 10-15% could benefit from this new treatment once established.

Currently, patients with extensive scarring of the cornea can only be treated in specialist centres where cells from the unaffected eye are cultured and grafted back to the scarred eye in a similar way, but using a human amniotic membrane (derived from donated placenta) to deliver them. While the success with this technique is good, there are less than 12 centres in the world, and only 3 in India, offering this technology to patients.

The new technique uses a synthetic membrane which will be available as a sterile packaged product without any risk of disease transmission. This makes it not only safer and cheaper but more readily available than relying on donated amniotic membranes, which can only be acquired if surgeons have access to Tissue Banks stocking these membranes. There are currently many areas in the world that cannot access amniotic membranes which are safe to use clinically.

I am delighted that these first in-man safety trials are getting underway in India with our colleagues at the LV Prasad Eye Institute. There are several other techniques being developed in this area, but the rationale behind our work was to make this treatment accessible for all patients in India and potentially worldwide. Ultimately, we hope success in these trials will go on to help millions of people to retain or potentially regain their sight.

Professor Sheila MacNeil / Professor of Tissue Engineering at the University of Sheffield

Treating corneal blindness is a particular problem in the developing world, where there are high instances of chemical or accidental damage to the eye. More complex treatments such as transplants or amniotic membrane grafts are not available to large proportions of the population due to the high costs and lack of appropriate healthcare facilities.

The technique we jointly developed not only significantly reduces the cost in comparison to other similar techniques, but significantly reduces the risk of contamination by using a synthetic material. We have developed an affordable technology and it is very satisfying to have seen it through from the fundamental research stage to these trials and hopefully soon, to commercial application.

Dr Stephen Caddick, Director of Innovations at the Wellcome Trust, said: “India has some of the highest levels of preventable blindness in the world. Yet limited access to affordable healthcare means that the best treatments are often unavailable to those in greatest need. By supporting the development of high-quality, affordable technologies, we intend to help more people in low and middle-income countries to benefit from the latest medical advances.”

The research is funded by the Wellcome Trust through an Affordable Healthcare in India Award, the objective of which is to fund translational research projects to deliver safe, effective and accessible healthcare products for India, and potentially other developing markets.